Genetic Study of Chronic Lymphocytic Leukemia Families

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mayo Clinic
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00503256
First received: July 16, 2007
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

The goal of this research is to identify genes that may be related to the risk of developing CLL.

Objectives:

The objective of this study to investigate possible candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL) by identifying and recruiting high-risk families. Through our ongoing study of familial aggregation in CLL kindreds (protocol 2003-0498 'Genetic Study of Chronic Lymphocytic Leukemia'), we have identified CLL patients who have one or more living relative(s) affected with CLL or other leukemias or lymphomas. We will also identify patients in high-risk families from referrals from leukemia clinicians and from self-referrals from patients who learn about our study from the ClinicalTrials.gov website. We plan to invite probands (patients diagnosed with CLL) and their family members with other leukemias and lymphomas and a sample of unaffected relatives to participate in a genetic/linkage study. We will obtain demographic and clinical information along with specimens (blood or buccal samples) from all participants. These families will be part of the Genetic Epidemiology of CLL Consortium, a multicenter, multidisciplinary consortium, based at the Mayo Clinic Cancer Center under the direction of Susan Slager, PhD.

Genotypic data will be analyzed at Mayo Clinic, and coded, de-identified data will be shared with the NIH Genome-Wide Association Studies (GWAS) data repository.


Condition Intervention
Leukemia
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genetic Study of Chronic Lymphocytic Leukemia Families

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL) [ Time Frame: Data collection over 6 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and cheek cell sample collection that will be used for special tests to look for genes that may play a role in the development of CLL.


Estimated Enrollment: 4000
Study Start Date: September 2003
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CLL - Linkage Families
Gene identification related to Chronic lymphocytic leukemia (CLL) development
Behavioral: Questionnaire
Questionnaires each taking 60 minutes to complete.
Other Name: Survey

Detailed Description:

This study does not involve taking any medications.

You will be asked to provide study personnel with authorization to request medical records from your physician, the hospital, and/or from other health care facilities where you were diagnosed with cancer. The information gathered will be used to help verify the diagnosis. Study personnel may also need to contact you in the future by phone, mail, or e-mail in order to ask questions about the status of your health.

For this research study, you will be asked to have around 4 tablespoons of blood drawn from a vein in your arm or you will also be asked to provide a sample of cheek cells by spitting into a collection container. The blood and cheek cell samples will be used for special tests to look for genes that may play a role in the development of CLL. You will also be asked to complete a family history questionnaire and a risk factor questionnaire. The family history questionnaire and the risk factor questionnaire will each take 60 minutes to complete. You will need to contact your family members before you send the completed family history questionnaire back to the study staff. You must ask for their permission to send the study staff their contact information. Family members with CLL or other leukemias or lymphomas, as well as a sample of your unaffected family members, will then be contacted by study personnel about participating in the study.

If you live in Houston, or the surrounding area, study personnel can arrange to collect the samples at the time and place of your convenience. If you do not live in the Houston area, sample collection instructions and supplies will be mailed to you. The blood sample may be drawn at your doctor's office, or at a clinic or hospital of your choice. All mailing costs will be paid by the study. No travel to M. D. Anderson will be required.

All blood and cheek cells collected will only be used by researchers involved in this study. Genetic information from the analysis of your blood and cheek cells will be included in a repository of genetic information at the National Institutes of Health, but no personal identifying information will be sent. All information will be kept confidential. Neither you nor your doctor will receive the results of these tests and they will NOT be put in your medical record.

This is an investigational study. Up to 450 participants will be enrolled by M. D. Anderson researchers. A total of 4000 participants will be enrolled in this multicenter study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with chronic lymphocytic leukemia (CLL) and their living unaffected or affected relatives.

Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed CLL who have living or dead relatives affected with CLL. They must agree to complete a risk factor questionnaire and a family history questionnaire, and to donate a 50mL blood specimen or a buccal specimen.
  2. Relatives of the CLL patients who have CLL or other lymphoproliferative disorders (i.e., leukemia & lymphoma). They must agree to complete a risk factor questionnaire and donate a 50mL blood specimen or a buccal specimen. They will need to sign an authorization to release their medical records so that we can confirm their diagnosis.
  3. A sample of unaffected relatives of the CLL patients. They must agree to complete a risk factor questionnaire and donate a 50mL blood specimen or a buccal specimen.

Exclusion Criteria:

1) No exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503256

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Mayo Clinic
Investigators
Principal Investigator: Sara Strom, PhD M.D. Anderson Cancer Center
Study Director: Susan Slager, Ph.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00503256     History of Changes
Other Study ID Numbers: ID03-0117
Study First Received: July 16, 2007
Last Updated: July 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Leukemia
Lymphoma
Questionnaire
Survey
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014